Janacti (sitagliptin/pioglitazone) / Merck (MSD) - LARVOL DELTA

Merck Sharp & Dohme (Europe), Inc. withdraws its marketing authorisation application for Janacti (sitagliptin and pioglitazone) and related trade names (European Medicines Agency) - EMA has been formally notified by Merck Sharp & Dohme (Europe), of its decision to withdraw its application for a centralized marketing authorization for medicine Janacti (sitagliptin and pioglitazone) & related trade names, 100/30mg & 100/45mg fixed-dose combination tablets intended to be used for treatment of adult patients with T2D; More information, together with the withdrawal letter from company, will be published on Agency’s website after next CHMP meeting on 14-17 November 2011

European application withdrawal • Diabetes

Efficacy and safety of initial combination therapy with sitagliptin and pioglitazone in patients with type 2 diabetes: A 54-week study (Diabetes Obes Metab) - P3, N=520; MK0431-064-10; At the end of the extension study (Week 54), the mean reduction in HbA(1c) was -2.4% with the combination of sitagliptin 100mg and pioglitazone 45mg vs. -1.9% with pioglitazone monotherapy (between-group difference [-0.5% [-0.8, -0.3]) and the mean reduction in FPG was -61.3 mg/dL vs. -52.8mg/dL, respectively (between-group difference=-8.5mg/dL [-16.3, -0.7])

P3 data • Diabetes